The National Institute on Aging (NIA) will accept applications for the Mentored Clinical Scientist Development Award (K08) or Mentored Research Scientist Award (K01) in the area of Alzheimer's disease and related dementias research to support the development of outstanding academic physician scientists to continue or to focus their research effort in Alzheimer's disease related to clinical practice.

The NIA intends to commit approximately $1 Million in FY 2006 to fund up to six new grants in response to this RFA.

• For-profit and non-profit organizations
• Public or private institutions, such as universities, colleges, hospitals, and laboratories
• Domestic institutions.
• Foreign institutions are not eligible to apply

Eligible principal investigators must have an M.D. or D.O. degree, must have completed postgraduate clinical training in a clinical area pertinent to the goals of this RFA such as Geriatric Medicine, Neurology, Psychiatry or Neuropathology and have a faculty appointment in an appropriate research-intensive environment with established facilities for Alzheimer's disease research comparable to an NIA-sponsored Alzheimer's Disease Center and have identified a mentor(s) with extensive Alzheimer's disease research experience.

The National Institute on Aging (NIA) will accept applications for the Mentored Clinical Scientist Development Award (K08) or Mentored Research Scientist Award (K01) in the area of Alzheimer's disease and related dementias research. NIA will offer the K08 or K01 award to support the development of outstanding academic physician scientists to continue or to focus their research effort in Alzheimer's disease related to clinical practice. These mechanisms provide support for a period of supervised research and study for either clinically trained professionals with little research experience but who have the commitment and the potential to develop into productive, independent Alzheimer's disease investigators (K08) or for clinically trained professionals with substantial research experience who wish to redirect their career to concentrate on Alzheimer's research (K01). The award period is three years and must include a plan to obtain didactic training and supervised training experience in order to ground the applicant in the field of neurodegenerative disease and integrate a fundamental and theoretical understanding of dementia with clinically oriented and/or laboratory research. Applications requesting more or less than 3 years of support will not be accepted. The proposed research should have both scientific importance and be a suitable vehicle for learning the skills necessary to become an independent physician-scientist concentrating on dementia research and practice. The scope and nature of the proposed research should also be suitable for potential development into an independently funded research endeavor. The research program should be designed to elicit results that can be translated into clinical practice.

This award will support developmental experiences in either clinical or laboratory research. Because of the focus on progression to independence as a researcher, the prospective candidate for the K08 or K01 award should propose a period of training consistent with this goal and his or her previous research and clinical experience. For example, a candidate with limited experience in dementia research may need a designated period of didactic training and closely supervised research experience for a longer period as the most efficient means of attaining independence. A candidate with substantial previous research experience, such as an investigator in another field redirecting his/her career focus into dementia research, may require a shorter didactic training period appropriate for the transition to independence. In all cases, the candidate must provide evidence of either having attained a broad understanding of theoretical aspects of the relevant clinical or basic science related to Alzheimer's disease and related dementias, or that s/he will attain the same during the course of this award.

You must devote at least 75% of your full-time professional effort to the goals of this award. You may devote the remainder to activities that are consistent with the purpose of the award and which allow you to develop the necessary experience, knowledge and skills to become an independent researcher in a clinically-relevant field.

This funding opportunity uses the just-in-time budget concepts. It also uses the non-modular budget format described in the PHS 398 application instructions (see https://grants.nih.gov/grants/funding/phs398/phs398.html). A detailed categorical budget for the "Initial Budget Period" and the "Entire Proposed Period of Support" is to be submitted with the application.

2. Funds Available

NIA intends to commit approximately $1 million dollars in FY 2006.

Up to 6 new awards are anticipated

Awards will be made for three years

Salary is allowed up to $100,000, plus fringe benefits, per year. Research development costs are allowed up to $50,000 per year. See additional detail on these costs below.

The anticipated start date is: September 15, 2006

Because the nature and scope of the proposed activities will vary from application to application it is anticipated that the size of each award will also vary. Although the financial plans of NIA provide support for this program, awards pursuant to this funding opportunity are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications.

Facilities and administrative costs requested by consortium participants are not included in the direct cost limitation, see NOT-OD-05-004.

Allowable Costs:

Salary: NIA will provide salary at a maximum of $ 100,000 per year plus fringe benefits. The institution may supplement the NIA contribution up to a level that is consistent with the institution's salary scale. Because the salary amount provided by this award is based on your full-time institutional salary, other PHS funds may not be used to supplement the salary. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of this award. Under Institution authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale. The total salary requested must be based on a 100%, 12-month staff appointment. It must be consistent both with the established salary structure at the institution and with salaries actually provided by the institution from its own funds to other staff members of equivalent qualifications, rank, and responsibilities in the department concerned. If full-time, 12-month salaries are not currently paid to comparable staff members, the salary proposed must be appropriately related to the existing salary structure. The salary awarded may be no more than the legislative cap in effect at the time of award. Information on the current legislative limit is available at: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-05-024.html.

At least 75% of full-time effort must be devoted to the goals of this award. Because the salary amount provided by this award is based on your full-time institutional salary, you may not use other PHS funds to supplement the salary. Institutional supplementation of salary must not require extra duties or responsibilities that would interfere with the purpose of this award. Under expanded authorities, however, institutions may rebudget funds within the total costs awarded to cover salaries consistent with the institution's salary scale provided that the resulting salary is within the current legislative cap.

If you obtain independent research funding as principal investigator of an NIH research grant award in the final two years of this award, at the time the new research grant is awarded, the effort required on the career award may be reduced to no less than 50 percent and replaced by effort from the research award so that the total level of research commitment remains at 75 percent or more for the duration of the mentored career award. See: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html for further details about this policy..

Research Development Support: NIA will provide up to $50,000 per year for: (a) research expenses such as supplies, equipment and technical personnel; (b) statistical services including personnel and computer time; (c) travel to research meetings or training; (d) tuition and fees related to career development.

Facilities and administrative costs: These costs, which were formerly called indirect costs, will be reimbursed at eight percent of modified total direct costs.

Section III. Eligibility Information

1. Eligible Applicants

1.A. Eligible Institutions

You may submit (an) application(s) if your organization has any of the following characteristics:

For-profit organizations

Non-profit organizations

Public or private institutions, such as universities, colleges, hospitals, and laboratories

Domestic Institutions

Foreign organizations/institutions are not eligible to apply.

1.B. Eligible Individuals

Candidates must have an M.D. or D.O. degree, must have completed postgraduate clinical training in a clinical area pertinent to the goals of this RFA such as Geriatric Medicine, Neurology, Psychiatry or Neuropathology and must have secured a faculty appointment in an appropriate research-intensive environment with established facilities for Alzheimer's disease research comparable to an NIA-sponsored Alzheimer's Disease Center, must identify a mentor with extensive Alzheimer's disease research experience, and must be willing to spend a minimum of 75 percent of full-time professional effort conducting research and research career development related to Alzheimer's disease and related dementias. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH programs.

At the time of the award, you must be a U.S. citizen or a non-citizen national, or must have been lawfully admitted for permanent residence and possess an Alien Registration Receipt Card (I-551) or have some other verification of legal admission as a permanent resident. Non-citizen nationals, although not U.S. citizens, owe permanent allegiance to the U.S. They are usually born in lands that are not states but are under U.S. sovereignty, jurisdiction, or administration. Individuals on temporary or student visas are not eligible.

Former principal investigators on NIH research project (R01), FIRST Awards (R29), former NIH career development (K) awardees, sub-projects of program project (P01) or center grants (P50), or the equivalent, are not eligible for the K08 award but may apply for the K01 award. If you apply for these K awards, then you may not concurrently apply for any other PHS award that duplicates the provisions of this award nor have another application pending award. Former principal investigators of NIH Small Grants (R03) or Exploratory/Developmental Grants (R21) remain eligible. Both K08 and K01 recipients are encouraged to apply for independent research grant support during the period of this award.

If you obtain independent research funding as principal investigator of an NIH research grant award in the final two years of this award, at the time the new research grant is awarded, the effort required on this career award may be reduced to no less than 50 per cent and replaced by the effort on the research award so that the total level of commitment remains at 75 percent or more for the duration of the mentored career award. See: https://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-007.html for further details about this policy.

Environment: The institution must have well-established research programs in Alzheimer's disease research including clinical facilities and basic laboratories similar to those of an NIA-sponsored Alzheimer's Disease Center. The institution must have experience with clinical career development programs and qualified faculty in clinical and basic research related to Alzheimer's disease and other neurodegenerative diseases to serve as mentors. The institution must be able to demonstrate a commitment to the development of the candidate as a productive, independent investigator. The candidate, the mentor and the institution must be able to describe an in-depth, broadly based career development program that will maximize the use of relevant research and educational resources.

Program: The goal of this program is to train junior and mid level physicians to focus their careers on Alzheimer's disease research and to apply basic knowledge of the disease process to clinical care of patients. There is a critical need to build better bridges between Alzheimer's laboratory research and cutting edge new methods of diagnosis, treatment and prevention of the disease. Well-trained physician scientists are needed to provide the next generation of leadership for research and treatment of Alzheimer's disease and the related dementias. The award provides for three consecutive 12 month periods. At least 75% of full-time professional effort must be devoted to this program. The remainder may be devoted to other clinical and teaching pursuits consonant with the objectives of the award. Both the didactic and basic science components must be designed to help the candidate develop the necessary knowledge and research skills in scientific areas relevant to career goals. (See DETERMINING FULL-TIME PROFESSIONAL EFFORT FOR CAREER AWARDS at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-04-056.html.

Mentor(s): Candidates must receive appropriate mentoring throughout the three-year program. A primary mentor must be named, who together with the candidate is responsible for the planning, direction, and execution of the program. The mentor(s) must have expertise in Alzheimer's disease and related dementias, have a funded research program, have a track record of success in training independent investigators, and demonstrate his/her availability and commitment to a clearly delineated training program.

Applications must be prepared using the most current PHS 398 research grant application instructions and forms. Applications must have a D&B Data Universal Numbering System (DUNS) number as the universal identifier when applying for Federal grants or cooperative agreements. The D&B number can be obtained by calling (866) 705-5711 or through the web site at http://www.dnb.com/us/. The D&B number should be entered on line 11 of the face page of the PHS 398 form.

The title and number of this funding opportunity must be typed on line 2 of the face page of the application form and the YES box must be checked.

Supplementary Instructions for Career Development awards are located in the PHS 398, Section III.

Note that applications responding to this announcement must include at least three sealed letters of reference attached to the face page of the original application. Applications submitted without the required number of reference letters will be considered incomplete and will be returned without review.

3. Submission Dates and Times Applications must be received on or before the receipt date described below (Section IV.3.A). Submission times N/A.

Prospective applicants are asked to submit a letter of intent that includes the following information:

Descriptive title of proposed research

Name, address, and telephone number of the Principal Investigator

Names of other key personnel

Participating institutions

Number and title of this funding opportunity

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

The letter of intent is to be sent by the date listed at the beginning of this document.

Applications must be prepared using the research grant applications found in the PHS 398 instructions for preparing a research grant application. Submit a signed, typewritten original of the application, including the checklist, and three signed photocopies in one package to:

Using the RFA Label: The RFA label available in the PHS 398 application instructions must be affixed to the bottom of the face page of the application. Type the RFA number on the label. Failure to use this label could result in delayed processing of the application such that it may not reach the review committee in time for review. In addition, the RFA title and number must be typed on line 2 of the face page of the application form and the YES box must be marked. The RFA label is also available at: https://grants.nih.gov/grants/funding/phs398/labels.pdf.

Appendix materials should be sent on a CD following the instructions for Appendix materials that begin in Part 1, page 36 of the PHS 398 form (rev. 9/2004). The complete appendix materials should be identified with the name of the principal investigator and the title of this RFA: Alzheimer's Disease Clinical Scientist Development Award. All appendix materials for the complete application should be on a single CD. Five copies of this CD should be sent to the Chief, Scientific Review Office, NIA (see address above).

3.C. Application Processing

Applications must be received on or before the application receipt date(s) described above (Section IV.3.A.). If an application is received after that date, it will be returned to the applicant without review. Upon receipt, applications will be evaluated for completeness by the CSR and responsiveness by the NIA. Incomplete and non-responsive applications will not be reviewed.

The NIH will not accept any application in response to this funding opportunity that is essentially the same as one currently pending initial review, unless the applicant withdraws the pending application. However, when a previously unfunded application, originally submitted as an investigator-initiated application, is to be submitted in response to a funding opportunity, it is to be prepared as a NEW application. That is, the application for the funding opportunity must not include an Introduction describing the changes and improvements made, and the text must not be marked to indicate the changes from the previous unfunded version of the application.

Although there is no immediate acknowledgement of the receipt of an application, applicants are generally notified of the review and funding assignment within eight (8) weeks.

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at https://grants.nih.gov/grants/policy/policy.htm.

Pre-Award Costs are allowable. A grantee may, at its own risk and without NIH prior approval, incur obligations and expenditures to cover costs up to 90 days before the beginning date of the initial budget period of a new or competing continuation award if such costs: are necessary to conduct the project, and would be allowable under the grant, if awarded, without NIH prior approval. If specific expenditures would otherwise require prior approval, the grantee must obtain NIH approval before incurring the cost. NIH prior approval is required for any costs to be incurred more than 90 days before the beginning date of the initial budget period of a new or competing continuation award.

The incurrence of pre-award costs in anticipation of a competing or non-competing award imposes no obligation on NIH either to make the award or to increase the amount of the approved budget if an award is made for less than the amount anticipated and is inadequate to cover the pre-award costs incurred. NIH expects the grantee to be fully aware that pre-award costs result in borrowing against future support and that such borrowing must not impair the grantee's ability to accomplish the project objectives in the approved time frame or in any way adversely affect the conduct of the project. See NIH Grants Policy Statement https://grants.nih.gov/archive/grants/policy/nihgps_2003/index.htm.

6. Other Submission Requirements

Using the Supplementary Instructions in the PHS 398 for Research Career Awards (Instructions, Part III), the following information must be included in the application.

The application must address the following:

Candidate:

Describe commitment to a career in clinical or laboratory-based biomedical research related to Alzheimer's disease and related dementias.

Provide evidence of the potential to develop into an independent investigator.

Describe immediate and long-term career objectives, explaining how the award will contribute to their attainment. For a K01 applicant, outline previous research experience and the rationale for redirecting research interests to Alzheimer's disease.

Include three sealed letters of reference addressing the candidate's potential for a research career. The mentor's statement (see below) must not be included as one of the required letters of reference. A co-mentor who is not the primary mentor may write a letter of reference.

Career Development Plan:

Describe a career development plan incorporating consideration of goals and prior experience. Where necessary, the application must describe a systematic plan to obtain both the necessary didactic training and research experience to launch an independent research career related to Alzheimer's disease and other dementias of aging. If interested in clinical research there must be a description of the availability of courses such as research design, biostatistics, epidemiology, and ethical and regulatory issues at the institution and the integration of these studies into the career development plan. Candidates having limited research training may need a phased developmental period including didactic training during the first year of the award while gradually phasing in a period of intense, supervised research experience. Those who have more experience at the time of application may need a shorter developmental period and may already have an adequate theoretical background. In any case, the career development plan must be tailored to particular needs and the ultimate goal of achieving independence as a researcher.

Research Plan:

Describe the research plan and the use of a clinical science or laboratory approach to a research project that will likely lead to increased knowledge or better treatment of Alzheimer's disease and/or related dementias. To describe the research plan follow the instructions in form PHS 398 including sections on the Specific Aims, Background and Significance, Progress Report/ Preliminary Studies, Research Design and Methods. The candidate should consult with his/her mentor regarding the development of this section. However, the proposed research should derive from the candidates own background, research interests, and career goals. The proposed research should also be suitable for development into a project capable of generating independent funding.

Studies that involve clinical trials (biomedical and behavioral intervention studies) must include a description of the plan for data and safety monitoring of the research and adverse event reporting to ensure the safety of subjects (see Federal Citations in Section VIII).

Statement(s) by Mentor(s)/Consultant(s)/Collaborator(s) :

The candidate must name a primary sponsor (or mentor), who, together with the applicant, is responsible for the planning, direction, and execution of the program. The candidate may also nominate co-mentors as appropriate to the goals of the program.

The mentor should be recognized for his or her research qualifications and previous experience as a research supervisor for training scientists in Alzheimer's disease, related dementias, or other neurodegenerative diseases.

The mentor should have sufficient independent research funding to support the proposed research project in excess of the allowable costs of this award.

Where feasible, women, individuals from diverse race and ethnic groups, and individuals with disabilities should be involved as mentors to serve as role models.

The application must include a statement from the mentor(s) providing: 1) information on their research qualifications and previous experience as a research supervisor; 2) a mentoring plan describing the nature of the supervision and mentoring that will occur during the proposed award period and 3) a plan for transitioning the candidate from the mentored phase of their careers to the independent investigator phase during the project period of the award.

The mentor must agree to provide annual evaluations of the candidate's progress for the duration of the award as required in the annual progress report, PHS 2590 (see Section VI.3 Reporting).

Similar information must be provided by any co-mentor. If more than one mentor is proposed, the respective areas of expertise and responsibility of each should be described. Co-mentors should clearly describe how they will coordinate the mentoring of the candidate.

Environment and Institutional Commitment to the Candidate:

The sponsoring institution must document a strong, well-established research and training program related to Alzheimer's disease and other neurodegenerative disease including a high quality research environment comparable to a NIA-sponsored Alzheimer's Disease Center with staff capable of productive collaboration with the candidate. The sponsoring institution also must provide a statement of commitment to the candidate's development into a productive, independent investigator. The institutional statement also must commit to provision of release time from normal clinical, teaching, or administrative duties necessary to meet the 75% effort requirement of this award. The statement should indicate that the sponsoring institution treats the candidate as a faculty member.

Training in the Responsible Conduct of Research:

Applications must include a description of a program to receive formal or informal instruction in scientific integrity or the responsible conduct of research. Applications without plans for instruction in the responsible conduct of research will be considered incomplete and may be returned to the applicant without review. Although the NIH does not establish specific curricula or formal requirements, all programs are encouraged to consider instruction in the following areas: conflict of interest, responsible authorship, policies for handling misconduct, policies regarding the use of human and animal subjects, and data management. Applicants must follow the application instructions found on page 49 of the PHS-398 application package and refer to the NIH web site (http://www.nih.gov/sigs/bioethics/researchethics.html) for additional guidance.

Document prior instruction in, and propose plans to receive, instruction in the responsible conduct of research in terms of subject matter and duration of instruction. An award cannot be made if an application lacks this component.

The adequacy of the resources sharing plan and any related data sharing plans will be considered by Program staff of the funding organization when making recommendations about funding applications. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590, https://grants.nih.gov/grants/funding/2590/2590.htm). See Section VI.3. Reporting.

Section V. Application Review Information

1. Criteria

The following will be considered in making funding decisions:

Scientific merit of the proposed project as determined by peer review

Availability of funds

Relevance of proposed program of research and career development activities to program priorities in Alzheimer's Disease research

2. Review and Selection Process

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by an appropriate peer review group convened by the NIA in accordance with the review criteria stated below.

As part of the initial merit review, all applications will:

Undergo a selection process in which only those applications deemed to have the highest scientific merit, generally the top half of applications under review, will be discussed and assigned a priority score.

Receive a written critique.

Receive a second level of review by the National Advisory Council on Aging

The goals of NIH supported research are to advance our understanding of biological systems, to improve the control of disease, and to enhance health. In their written critiques, reviewers will be asked to comment on each of the following criteria in order to judge the likelihood that the proposed research will have a substantial impact on the pursuit of these goals:

Candidate

Career Development Plan

Research Plan

Training in the Responsible Conduct of Research

Appropriateness of and statements by Mentor, Co-Mentor(s), Consultant(s), and Collaborator(s)

Environment and Institutional Commitment to the Candidate

The application does not need to be strong in all categories to receive a high priority score. These criteria are listed in logical order and not in order of priority .

Candidate:

Quality of academic and clinical record;

Potential through this award to develop as an independent clinical or laboratory based researcher in the field of Alzheimer's disease;

Commitment to a career in Alzheimer's research and clinical practice

Quality of the letters of reference from three well-established scientists submitted on your behalf and addressing your potential to become an independent investigator and a leader in clinically relevant research. A support letter from your lead mentor will be considered separately from these letters.

Career Development Plan:

Likelihood that the career development plan will contribute substantially to candidate's scientific development;

Probability of development of a competitive independent research program;

Documentation of local expertise in Alzheimer's disease and other neurodegenerative diseases and appropriateness of the content and duration of the proposed didactic and research phases of the award;

Consistency of the career development plan in light of career goals and prior research experience;

Training in the Responsible Conduct of Research:

Appropriateness and quality of the proposed training in the responsible conduct of research.

Research Plan:

Reviewers recognize that applicants will have variable amounts of previous research experience and that an individual with limited research experience is less likely to be able to prepare a research plan with the breadth and depth of that submitted by a more experienced investigator. Although it is understood that K08 and K01 applications do not require the level of detail necessary in regular research grant proposals, a fundamentally sound research plan must be provided. The following details should be provided:

The significance of the area of dementia research in which the candidate proposes to establish independence;

Appropriateness of the research plan to the stage of research development and as a vehicle for developing the research skills as described in the career development plan;

Scientific and technical merit of the research question, design and methodology and its likelihood to advance dementia research;

Relevance of the proposed research to career objectives;

Adequacy of the plan's attention to gender and minority issues associated with projects involving human subjects.

Statement(s) by Mentor(s)/Consultant(s)/Collaborator(s):

Appropriateness of mentor's statement of support and research qualifications in Alzheimer's disease and related dementias;

Quality and extent of commitment of the mentor's proposed role in providing guidance and advice;

Previous experience in fostering the development of Alzheimer's researchers;

History of research productivity and support; and

Adequacy of support for the proposed research.

Environment and Institutional Commitment:

Institution's commitment to the candidate's scientific development and assurances that the institution intends for the candidate to be an integral part of its research program;

Adequacy of research facilities (comparable to those of an NIA-sponsored Alzheimer's Disease Center) and availability of appropriate educational opportunities;

Quality and relevance of the environment for the candidate's scientific and professional development;

Institution's commitment to an appropriate balance of research and clinical responsibilities including the level of 75 percent effort proposed.

2.A. Additional Review Criteria:

In addition to the above criteria, the following items will continue to be considered in the determination of scientific merit and the priority score:

Protection of Human Subjects from Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Inclusion of Women and Minorities in Research: The adequacy of plans to include subjects from both genders and all racial and ethnic groups (and subgroups), as appropriate for the scientific goals of the research, will be assessed. Plans for the recruitment and retention of subjects will also be evaluated (see the Research Plan, Section E on Human Subjects in the PHS Form 398).

Care and Use of Vertebrate Animals in Research: If vertebrate animals are to be used in the project, the five items described under Section F of the PHS Form 398 research grant application instructions will be assessed.

Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

2.B. Additional Review Considerations

Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research. The priority score should not be affected by the evaluation of the budget.

Program staff will be responsible for the administrative review of the plan for sharing research resources.

The adequacy of the resources sharing plan will be considered by Program staff of the funding organization when making recommendations about funding applications. Program staff may negotiate modifications of the resource sharing plans with the awardee before recommending funding of an application. The final version of the resource sharing plans negotiated by both will become a condition of the award of the grant. The effectiveness of the resource sharing will be evaluated as part of the administrative review of each non-competing Grant Progress Report (PHS 2590). See Section VI.3. Reporting.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the NoA will be generated via email notification from the awarding component to the grantee business official (designated in item 14 on the Application Face Page). If a grantee is not email enabled, a hard copy of the NoA will be mailed to the business official.

Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. See Also Section IV.5. Funding Restrictions.

2. Administrative and National Policy Requirements

The following related administrative policies apply to NIH Research Career Award (“K”) programs:

Evaluation: In carrying out its stewardship of human resource related programs, the NIA may request information essential to an assessment of the effectiveness of this program. Accordingly, recipients are hereby notified that they may be contacted after the completion of this award for periodic updates on various aspects of their employment history, publications, support from research grants or contracts, honors and awards, professional activities, and other information helpful in evaluating the impact of the program.

Other Income: Awardees may retain royalties and fees for activities such as scholarly writing, service on advisory groups, honoraria from other institutions for lectures or seminars, fees resulting from clinical practice, professional consultation or other comparable activities, provided these activities remain incidental, are not required by the research and research-related activities of this award, and provided that the retention of such pay is consistent with the policies and practices of the grantee institution. All other income and fees, not included in the preceding paragraph as retainable, may not be retained by the career award recipient. Such fees must be assigned to the grantee institution for disposition by any of the following methods:

The funds may be expended by the grantee institution in accordance with the NIH policy on supplementation of career award salaries and to provide fringe benefits in proportion to such supplementation. Such salary supplementation and fringe benefit payments must be within the established policies of the grantee institution.

The funds may be used for health-related research purposes.

The funds may be paid to miscellaneous receipts of the U.S. Treasury. Checks should be made payable to the Department of Health and Human Services, NIH and forwarded to the Director, Office of Financial Management, NIH, Bethesda, Maryland 20892. Checks must identify the relevant award account and reason for the payment. Usually, funds budgeted in an NIH supported research or research training grant for the salaries or fringe benefits of individuals, but freed as a result of a career award, may not be rebudgeted. NIA will consider approval for the use of released funds only under unusual circumstances.

Special Leave: Leave to another institution, including a foreign laboratory, may be permitted if directly related to the purpose of the award. Only local, institutional approval is required if such leave does not exceed three months. For longer periods, prior written approval of NIA is required. To obtain prior approval, you must submit a letter to NIA describing the plan, countersigned by your department head and the appropriate institutional official. A copy of a letter or other evidence from the institution where the leave is to be taken must be submitted to assure that satisfactory arrangements have been made. Support from the career award will continue during such leave. Leave without award support may not exceed 12 months. Such leave requires the prior written approval of NIA and will be granted only in unusual situations. Support from other sources is permissible during the period of leave. Such leave does not reduce the total number of months of program support for which an individual is eligible. Parental leave will be granted consistent with the policies of the NIH and the grantee institution.

Under unusual and pressing circumstances, an awardee may submit a written request to the awarding component requesting a reduction in professional effort below 75%. Such requests will be considered on a case-by-case basis during the award period. In no case will it be permissible to work at less than 50% effort. The nature of the circumstances requiring reduced effort might include medical conditions, disability, or pressing personal or family situations such as child or elder care. Permission to reduce the level of effort will not be approved to accommodate job opportunities, clinical practice, or clinical training. In each situation, the grantee institution must submit documentation supporting the need for reduced effort along with assurance of a continuing commitment to the scientific development of the awardee. In addition, the awardee must submit assurance of his/her intention to return to at least 75% as soon as possible. During the period of reduced effort, the salary and other costs supported by the award will be reduced accordingly.

Termination or Change of Institution: When a grantee institution plans to terminate an award, NIA must be notified in writing at the earliest possible time so that appropriate instructions can be given for termination. If you are moving to another eligible institution, career award support may be continued provided:

The new institution submits an application to transfer the award, complete with the requisite information concerning all aspects of the career development plan, mentoring, and institutional support (as described elsewhere in this RFA);

The period of support requested is no more than the time remaining within the existing project period; and the application to transfer an award is submitted at least 60 days prior to the requested start date at the new institution to allow time for review by NIA staff.

The Director of the NIH may discontinue an award upon determination that the purpose or terms of the award are not being fulfilled. In the event an award is terminated, the Director of the NIH shall notify the grantee institution and career award recipient in writing of this determination, the reasons therefore, the effective date, and the right to appeal the decision.

A final progress report, invention statement, and Financial Status Report are required upon either termination of an award or relinquishment of an award in a change of institution situation.

Changes in Research Program: Individual awards are made for career development at a specific institution in a specific research program. A change in the specified scientific area of the research component of the career development program requires prior approval of the awarding NIH institute. A scientific rationale must be provided for any proposed changes in the aims of the original peer-reviewed research plan. The new research plan will be evaluated by staff of the awarding NIH component institute to ensure that the plan remains within the scope of the original peer-reviewed research program. If the new plan does not satisfy this requirement, staff could recommend that the award be terminated.

We encourage your inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues:

Human Subjects Protection:
Federal regulations (45CFR46) require that applications and proposals involving human subjects must be evaluated with reference to the risks to the subjects, the adequacy of protection against these risks, the potential benefits of the research to the subjects and others, and the importance of the knowledge gained or to be gained (http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm).

Data and Safety Monitoring Plan:
Data and safety monitoring is required for all types of clinical trials, including physiologic toxicity and dose-finding studies (phase I); efficacy studies (Phase II); efficacy, effectiveness and comparative trials (Phase III). Monitoring should be commensurate with risk. The establishment of data and safety monitoring boards (DSMBs) is required for multi-site clinical trials involving interventions that entail potential risks to the participants (NIH Policy for Data and Safety Monitoring, NIH Guide for Grants and Contracts, https://grants.nih.gov/grants/guide/notice-files/not98-084.html).

Sharing Research Data:
Investigators submitting an NIH application seeking $500,000 or more in direct costs in any single year are expected to include a plan for data sharing or state why this is not possible (https://grants.nih.gov/grants/policy/data_sharing).

Investigators should seek guidance from their institutions, on issues related to institutional policies and local IRB rules, as well as local, State and Federal laws and regulations, including the Privacy Rule. Reviewers will consider the data sharing plan but will not factor the plan into the determination of the scientific merit or the priority score.

Access to Research Data through the Freedom of Information Act:
The Office of Management and Budget (OMB) Circular A-110 has been revised to provide access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. It is important for applicants to understand the basic scope of this amendment. NIH has provided guidance at https://grants.nih.gov/grants/policy/a110/a110_guidance_dec1999.htm. Applicants may wish to place data collected under this funding opportunity in a public archive, which can provide protections for the data and manage the distribution for an indefinite period of time. If so, the application should include a description of the archiving plan in the study design and include information about this in the budget justification section of the application. In addition, applicants should think about how to structure informed consent statements and other human subjects procedures given the potential for wider use of data collected under this award.

Sharing of Model Organisms:
NIH is committed to support efforts that encourage sharing of important research resources including the sharing of model organisms for biomedical research (see https://grants.nih.gov/grants/policy/model_organism/index.htm). At the same time the NIH recognizes the rights of grantees and contractors to elect and retain title to subject inventions developed with Federal funding pursuant to the Bayh Dole Act (see the NIH Grants Policy Statement https://grants.nih.gov/archive/archive/grants/policy/nihgps_2003/index.htm). All investigators submitting an NIH application or contract proposal, beginning with the October 1, 2004 receipt date, are expected to include in the application/proposal a description of a specific plan for sharing and distributing unique model organism research resources generated using NIH funding or state why such sharing is restricted or not possible. This will permit other researchers to benefit from the resources developed with public funding. The inclusion of a model organism sharing plan is not subject to a cost threshold in any year and is expected to be included in all applications where the development of model organisms is anticipated.

Inclusion of Women And Minorities in Clinical Research:
It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH-supported clinical research projects unless a clear and compelling justification is provided indicating that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing clinical research should read the "NIH Guidelines for Inclusion of Women and Minorities as Subjects in Clinical Research (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-001.html); a complete copy of the updated Guidelines is available at https://grants.nih.gov/grants/funding/women_min/guidelines_amended_10_2001.htm. The amended policy incorporates: the use of an NIH definition of clinical research; updated racial and ethnic categories in compliance with the new OMB standards; clarification of language governing NIH-defined Phase III clinical trials consistent with the new PHS Form 398; and updated roles and responsibilities of NIH staff and the extramural community. The policy continues to require for all NIH-defined Phase III clinical trials that: a) all applications or proposals and/or protocols must provide a description of plans to conduct analyses, as appropriate, to address differences by sex/gender and/or racial/ethnic groups, including subgroups if applicable; and b) investigators must report annual accrual and progress in conducting analyses, as appropriate, by sex/gender and/or racial/ethnic group differences.

Required Education on the Protection of Human Subject Participants:
NIH policy requires education on the protection of human subject participants for all investigators submitting NIH applications for research involving human subjects and individuals designated as key personnel. The policy is available at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-00-039.html.

Human Embryonic Stem Cells (hESC):
Criteria for federal funding of research on hESCs can be found at http://stemcells.nih.gov/index.asp and at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-02-005.html. Only research using hESC lines that are registered in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (http://escr.nih.gov). It is the responsibility of the applicant to provide in the project description and elsewhere in the application as appropriate, the official NIH identifier(s) for the hESC line(s)to be used in the proposed research. Applications that do not provide this information will be returned without review.

NIH Public Access Policy:
NIH-funded investigators are requested to submit to the NIH manuscript submission (NIHMS) system (http://www.nihms.nih.gov) at PubMed Central (PMC) an electronic version of the author's final manuscript upon acceptance for publication, resulting from research supported in whole or in part with direct costs from NIH. The author's final manuscript is defined as the final version accepted for journal publication, and includes all modifications from the publishing peer review process.

NIH is requesting that authors submit manuscripts resulting from 1) currently funded NIH research projects or 2) previously supported NIH research projects if they are accepted for publication on or after May 2, 2005. The NIH Public Access Policy applies to all research grant and career development award mechanisms, cooperative agreements, contracts, Institutional and Individual Ruth L. Kirschstein National Research Service Awards, as well as NIH intramural research studies. The Policy applies to peer-reviewed, original research publications that have been supported in whole or in part with direct costs from NIH, but it does not apply to book chapters, editorials, reviews, or conference proceedings. Publications resulting from non-NIH-supported research projects should not be submitted.

Standards for Privacy of Individually Identifiable Health Information:
The Department of Health and Human Services (DHHS) issued final modification to the "Standards for Privacy of Individually Identifiable Health Information", the "Privacy Rule", on August 14, 2002 . The Privacy Rule is a federal regulation under the Health Insurance Portability and Accountability Act (HIPAA) of 1996 that governs the protection of individually identifiable health information, and is administered and enforced by the DHHS Office for Civil Rights (OCR).

Decisions about applicability and implementation of the Privacy Rule reside with the researcher and his/her institution. The OCR website (http://www.hhs.gov/ocr/) provides information on the Privacy Rule, including a complete Regulation Text and a set of decision tools on "Am I a covered entity?" Information on the impact of the HIPAA Privacy Rule on NIH processes involving the review, funding, and progress monitoring of grants, cooperative agreements, and research contracts can be found at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-025.html.

URLs in NIH Grant Applications or Appendices:
All applications and proposals for NIH funding must be self-contained within specified page limitations. Unless otherwise specified in an NIH solicitation, Internet addresses (URLs) should not be used to provide information necessary to the review because reviewers are under no obligation to view the Internet sites. Furthermore, we caution reviewers that their anonymity may be compromised when they directly access an Internet site.

Healthy People 2010:
The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2010," a PHS-led national activity for setting priority areas. This PA is related to one or more of the priority areas. Potential applicants may obtain a copy of "Healthy People 2010" at http://www.health.gov/healthypeople.

Authority and Regulations: This program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The NIH Grants Policy Statement can be found at https://grants.nih.gov/grants/policy/policy.htm.

The PHS strongly encourages all grant recipients to provide a smoke-free workplace and discourage the use of all tobacco products. In addition, Public Law 103-227, the Pro-Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care, or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.

Loan Repayment Programs:
NIH encourages applications for educational loan repayment from qualified health professionals who have made a commitment to pursue a research career involving clinical, pediatric, contraception, infertility, and health disparities related areas. The LRP is an important component of NIH's efforts to recruit and retain the next generation of researchers by providing the means for developing a research career unfettered by the burden of student loan debt. Note that an NIH grant is not required for eligibility and concurrent career award and LRP applications are encouraged. The periods of career award and LRP award may overlap providing the LRP recipient with the required commitment of time and effort, as LRP awardees must commit at least 50% of their time (at least 20 hours per week based on a 40 hour week) for two years to the research. For further information, please see: http://www.lrp.nih.gov.